A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00219167
• Lead Sponsor: Novartis

Brief Summary

After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks
Change from baseline in sitting systolic and diastolic blood pressure after 8 weeks
Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks
Blood pressure control target of < 140/90 mmHg after 8 weeks
Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland